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NCT01321346 · ClinicalTrials.gov registry record · Phase 1
A Study Of Panobinostat In Children With Refractory Hematologic Malignancies
A Phase 1 study, sponsored by Therapeutic Advances in Childhood Leukemia Consortium.
- Completed
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
NCT01321346: Completed Phase 1 study, sponsored by Therapeutic Advances in Childhood Leukemia Consortium.
NCT01321346 is a Phase 1 study that has completed, run by Therapeutic Advances in Childhood Leukemia Consortium. The registered enrollment target is 30 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01321346, a Phase 1 study, has completed, sponsored by Therapeutic Advances in Childhood Leukemia Consortium.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
Study Summary
This study is for patients with relapsed or refractory Acute Lymphoblastic Leukemia (ALL), Acute Myelogenous Leukemia (AML), Hodgkin's Disease (HD) or Non-Hodgkin's Lymphoma (NHL). Panobinostat is a new drug that is considered investigational because it has not been approved in the United States by the Food and Drug Administration (FDA), or in any other country. Panobinostat is a histone deacetylase inhibitor (HDACi) and interferes with gene expression found in cells causing them to stop growing or die. Panobinostat has been used in several hundred adults who had leukemia, HD, NHL and other solid tumors. Panobinostat has not been given to children. This is a phase I study. In a phase I study, drugs are tested to the highest dose that can be safely given. Drugs are given at gradually increasing dosages until there are unacceptable side effects. The goal of the Phase I study is to find out the dose of panobinostat that can be safely given to children with relapsed ALL, AML, HD and NHL.
Interventions
- DRUG Cytarabine
- DRUG Panobinostat
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2011-03 |
| Phase | Phase 1 |
What the finished NCT01321346 record still lists
NCT01321346 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower).
The record links to 0 conditions, and to 2 interventions - of which Cytarabine is the first listed.
NCT01321346 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01321346 about?
NCT01321346 is a clinical study titled "A Study Of Panobinostat In Children With Refractory Hematologic Malignancies". This study is for patients with relapsed or refractory Acute Lymphoblastic Leukemia (ALL), Acute Myelogenous Leukemia (AML), Hodgkin's Disease (HD) or Non-Hodgkin's Lymphoma (NHL). Panobinostat is a new drug that is considered investigational because it has not been approved in the United States by ...
What is the current status of trial NCT01321346?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2011-03.
What interventions are being tested in trial NCT01321346?
The interventions under investigation include: Cytarabine (DRUG), Panobinostat (DRUG).
Who is sponsoring clinical trial NCT01321346?
This trial is sponsored by Therapeutic Advances in Childhood Leukemia Consortium, which has 19 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01321346's enrollment target sits among peer trials
30 1332nd of 2000 higher than 561 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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